Ipca-Ranbaxy alliance to market Metformin HCL tablets in US
14 Aug 2007
Mumbai: Ipca Laboratories which has formed a strategic alliance with Ranbaxy Laboratories'' US subsidiary Ranbaxy Pharmaceuticals Inc., has received approval from US Food and Drugs Administration to manufacture and market Metformin Hydrochloride USP tablets 500mg, 850mg and 1000mg in the US market.
Under the strategic alliance, Ohm Laboratories, Inc., a wholly owned subsidiary of RLL has now received approval from US Food and Drugs Administration to manufacture and market Metformin Hydrochloride USP tablets 500mg, 850mg and 1000mg in the US market.
Metformin HCL tablets has total annual market sales of $ 379 millions in the US, according IMS-MAT March 2007 data..
This is the fifth such product approval received under the alliance from US FDA, Ipca said in a filing with the Bombay Stock Exchange (BSE).
The company will manufacture this formulation utilising its facilities in India. It is setting up a new formulations manufacturing facility meeting US regulatory requirements at SEZ Indore. The company is already holding US DMF of Metformin HCL.
Ranbaxy will commercialise this product in the US market utilising its established marketing expertise and distribution network.